"FDA's CBER Issues Final Guidance For CAR-T Cell Products" by Anne Lamontagne and Wendy Liang

February 15, 2024
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"FDA's CBER Issues Final Guidance For CAR-T Cell Products," a guest column by DHC Senior Consultants Anne Lamontagne, M.S. and Wendy Liang., is hot off the presses today...courtesy of Life Science Connect's cellandgene.com.

"The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29 The guidance document was well-received when it was first issued as a draft in March 2022, according to the majority of docket comments posted on the Federal Register. Comments were prepared by various professional societies, therapeutic developers, academic institutions, and other contributors. A few significant changes were made to the document since the draft, and points of additional clarity were added throughout each section, in line with many of the comments posted."

...continue reading the full article here.

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